For the past several weeks, various allegations and
characterizations have circulated and been reported on regarding FDA's approval
and post market review
of the drug Vioxx, a "Cox-2 inhibitor," that its sponsor, Merck, voluntarily
withdrew from the market September 30th, 2004. I am issuing this statement to
further clarify the Agency's activities in this area. It covers four topics:

Issues involving allegations about the performance of
FDA's Office of Drug Safety;

Allegations about a scientific paper submitted to the British medical
journal, The Lancet;

The possible participation of Dr. Curt Furberg in an upcoming FDA
advisory committee to discuss Cox-2
inhibitors; and

Further information about FDA's recent announcements to strengthen its
safety program for marketed drugs.

First, allegations have surfaced about the handling of
the post-market review commissioned by the FDA and managed by the Center for
Drug Evaluation's Office of Drug Safety (ODS). In particular, there has been
concern about the process
used to complete that study and publish it, including allegations that ODS
managers disagreed with the project officer's conclusions and sought to modify
them. It is critical that all the facts be presented in this case to assure
public confidence in our drug safety programs.